FDAFDA · Food and drugs·Recall number Z-2493-2026

MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Kit Number/SKU DYNJ909989B; 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53214; 5) DIAGNOSTIC LAPAROSCOPY, Medline Kit Number/SKU DYNJ903390K; 6) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700C; 7) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700D; 8) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700F; 9) GENERAL-CVOR MINOR, Medline Kit Number/SKU DYNJ64324A; 10) GYN LAP, Medline Kit Number/SKU DYNJT7061; 11) GYN LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53631F; 12) GYN MINOR PACK, Medline Kit Number/SKU DYNJ85910; 13) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117A; 14) LAP, Medline Kit Number/SKU DYNJ904585B; 15) LAP, Medline Kit Number/SKU DYNJ904585C; 16) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255R; 17) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255S; 18) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255T; 19) LAPAROSCOPY, Medline Kit Number/SKU DYNJ89908; 20) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517; 21) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517A; 22) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958I; 23) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958J; 24) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992C; 25) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992D; 26) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992F; 27) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992G; 28) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992I; 29) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ67160; 30) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ84211; 31) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJHS0235C; 32) LAPAROSCOPY PACK VICTORY, Medline Kit Number/SKU DYNJ81148; 33) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ14073B; 34) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404A; 35) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404B; 36) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404C; 37) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404D; 38) LAPAROSCOPY/GYN PACK, Medline Kit Number/SKU DYNJ0384702U; 39) PACK LAPAROSCOPY, Medline Kit Number/SKU DYNJ0553254O; 40) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046A; 41) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046B; 42) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046C; 43) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046D; 44) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046F; 45) PROLAPSE PACK, Medline Kit Number/SKU DYNJ85390; 46) RICH CYSTO, Medline Kit Number/SKU DYNJ902183I; 47) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263B; 48) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263C; 49) SMJ LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ25763J; 50) WCH GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700G.

Published June 24, 2026 · Recall initiated: May 4, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: Medline Industries, LP
Distributor: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Lot: DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 26BBD116; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 26ABL500; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25FBH410; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25EBQ051; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25DBS969; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24LBQ812; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24LBF658; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24JBM406; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 23GBM492; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22IBV269; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22HBV981; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22HBF916; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25GBW197; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25GBD634; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25FBB533; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25EBC752; DYNJ53214: UDI/DI 10889942388301 (each), 40889942388302 (case), Lot Number 21HMG546; DYNJ53214: UDI/DI 10889942388301 (each), 40889942388302 (case), Lot Number 21HMC179; DYNJ903390K: UDI/DI 10198459522826 (each), 40198459522827 (case), Lot Number 26ABQ562; DYNJ903390K: UDI/DI 10198459522826 (each), 40198459522827 (case), Lot Number 25JBB643; DYNJ902700C: UDI/DI 10889942253876 (each), 40889942253877 (case), Lot Number 21EBL762; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23GBH673; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23GBH781; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23DBI173; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23DBJ926; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23BBG583; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23ABT448; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 21IBA024; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 21IBA023; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 24BBP837; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 24BBP021; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 23LBL539; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25FBC637; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25EBF271; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25CBK107; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 24GBH161; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 24BBQ307; DYNJT7061: UDI/DI 10198459594816 (each), 40198459594817 (case), Lot Number 25LBJ399; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 22CBU291; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 22BBB868; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21LBW055; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21IBQ254; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21EBR254; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21DBO515; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21DBE409; DYNJ53631F: UDI/DI 10193
Risk classification: Class II
Area (FDA): device
Country: United States

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